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CO-AMILOZIDE 5/50MG TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / HYDROCHLOROTHIAZIDE

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CO-AMILOZIDE:00411015-03........180mm X 297mm

10/29/15

4:41 PM

Page 1

Patient information leaflet

CO-AMILOZIDE 5/50MG TABLETS

Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• Keep the leaflet. You may need to read it again.
• If you have any other questions, or if there is something
you do not understand, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Never
give it to someone else. It may not be the right medicine
for them even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
In this leaflet:
1. What Co-amilozide is and what it is used for
2. What you need to know before you take Co-amilozide
3. How to take Co-amilozide
4. Possible side effects
5. How to store Co-amilozide
6. Contents of the pack and other information

1. What Co-amilozide is and what it is used for

Co-amilozide belongs to a group of medicines called
diuretics (water tablets). Diuretics work by helping the body
to dispose of excess water by urination.
This medicine is used to treat:
• high blood pressure
• congestive heart failure
• liver cirrhosis with fluid retention (oedema) and swelling
of the abdomen (ascites)

2. What you need to know before you take Coamilozide

Do NOT take Co-amilozide if you:
• are allergic to amiloride hydrochloride or
hydrochlorthiazide or other sulphonamides or any of the
other ingredients of this medicine (listed in section 6)
• have difficulty in passing urine
• suffer from Addison’s disease, gout or diabetes
• have kidney or liver disease
• are below the age of 18

Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets
if you:
• suffer from gestational oedema or hypertension
• have a condition known as systemic lupus erythematosus
• have been told that you have high levels of potassium in
your blood (hyper kalaemia)
• are pregnant, planning to become pregnant or breast
feeding
• have a lung disease or heart trouble

Other medicines and Co-amilozide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, especially:
• potassium supplements
• other potassium-sparing diuretics or ‘’water tablets’’ used
for high blood pressure or fluid retention (e.g.
spironolactone, triamterene)
• non-steroidal anti-inflammatory drugs (NSAIDs), used to
reduce fever or to relive pain or the symptoms of arthritis
(e.g. aspirin, ibuprofen)
• medicines used to treat high blood pressure or a heart
condition (e.g. digoxin and ACE inhibitors, such as
captopril and enalapril)
• lithium, used for treatment of depression
• barbiturates, which are used to help you sleep or reduce
anxiety (e.g. amobarbital)
• narcotic painkillers (e.g. codeine, morphine)
• certain muscle relaxants (e.g. tubocurarine)
• corticosteroids e.g. hydrocortisone
• corticotrophin (ACTH)

antidiabetic drugs such as insulin or chlorpropramide
noradrenaline, for serious allergic reactions
antacids (indigestion remedies)
cisplatin (used in some types of cancer)
colestyramine (used to reduce cholesterol)
tetracycline (used to treat bacterial infections)
ciclosporin and tacrolimus (used to suppress the immune
system)
• lignocaine, flecainide, atomoxetine, sertindole, sotalol








Co-amilozide with food, drink and alcohol
• Drinking alcohol while taking this medicine may cause
dizziness or light-headedness. Talk to your doctor before
taking alcohol (particularly if you have liver problems).
• You should not, take potassium supplements or eat foods
with high potassium content (such as bananas) whilst
taking this medicine.

Pregnancy and breast feeding

Pregnancy: You must tell your doctor if you are pregnant or
if you think that you are. Usually, your doctor will advise
you to take another medicine instead of Co-Amilozide, as
Co-Amilozide is not recommended during pregnancy. This is
because Co-Amilozide crosses the placenta and its use after
the third month of pregnancy may cause potentially harmful
foetal and neonatal effects.

Breast-feeding: Tell your doctor if you are breast-feeding or
about to start breast-feeding. Co-amilozide is not
recommended for mothers who are breast-feeding.
Driving and using machines
As this medicine may make you drowsy, you should not
drive or operate machinery until you know how the drug
affects you.

Co-amilozide tablets contains lactose & sunset yellow
(E110)
Lactose - These tablets contain lactose. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking these tablets.
Sunset yellow (E110) - this colouring agent may cause
allergic reactions.
Diabetic tests
If you are to be tested for diabetes or need to have other tests
related to diabetes, tell your doctor that you are taking Coamilozide tablets.
The tablets may need to be stopped at least three days before
the test, as they can interfere with the results.

3. How to take Co-amilozide

Always take this medicine exactly as described in this leaflet
or as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. The pharmacist’s label should
tell you how much to take and how often. If it does not or
you are not sure ask your doctor or pharmacist. The tablets
should be swallowed with a glass of water.

Adults:
The number of tablets to be taken is dependent on the disease
that you are being treated for. The following are typical doses
for each disease state.
Hypertension: Usually Co-Amilozide 2.5/25mg (equivalent
to half a tablet) given once a day. If necessary, increase to a
maximum of one tablet daily (Co-Amilozide 5/50mg).
Congestive heart failure: Initially Co-Amilozide 2.5/25mg
(equivalent to half a tablet) given once a day, subsequently
adjusted if required, but not exceeding 2 tablets (CoAmilozide 5/50mg) a day.
Hepatic cirrhosis with ascites: Initiate therapy with a low
dose. A single daily dose of one Co-Amilozide 5/50mg tablet
may be increased gradually until there is an effective dieresis.
Dosage should not exceed two tablets a day.

CO-AMILOZIDE:00411015-03........180mm X 297mm

10/29/15

Use in the elderly:
Particular caution is needed in the elderly because of their
susceptibility to electrolyte imbalance. The dosage should be
carefully adjusted to renal function and clinical response.
Children:
This tablet is not recommended for use in children under
18 years of age.
All patients, especially elderly patients, should be under
regular supervision by their doctor while taking this
medicine.
If you take more tablets than you should
If you or anyone else has taken too many tablets, contact
your nearest hospital casualty department or doctor
immediately. Take any remaining tablets with you to show
the doctor.

If you forget to take a dose
If you forget to take a dose, take the next dose as soon as you
remember, then go on as before. If you miss a day, do not
take a double dose the following day but continue as
prescribed by your doctor.
If you stop taking these tablets
Do not stop taking these tablets without first talking to your
doctor. If you stop taking your medicine your condition may
get worse. Treatment should continue for as long as your
doctor feels it is needed.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-amilozide tablets can cause side
effects, although not everybody gets them.
If you experience any of the following side effects tell your
doctor immediately:
• anaphylactic reaction (serious allergic reaction which
causes difficulty in breathing or dizziness)
• skin rashes, itching for the first time, wheezing or
swelling of the face, bleeding or easy bruising
• yellowing of your skin or the whites of your eyes caused
by liver or blood problems (jaundice)
• muscle pains or cramps
• inflammation of the pancreas (pancreatitis) which causes
severe pain in the abdomen and back (may be associated
with nausea, vomiting or fever)
• altered numbers and types of blood cells causing
increased bruising, nosebleeds, sore throats, infections,
excessive tiredness, breathlessness on exertion or
abnormal paleness of the skin
• depression
• irregular (arrhythmia) or fast (tachycardia) heart beats,
inflammation of blood vessels (necrotising angiitis)
• inability to control bladder movements, kidney failure or
inflammation

Other side effects:
Altered balance of fluid or chemicals in the body (e.g.
sodium, potassium, chlorine and magnesium) causing a dry
mouth, weakness, tiredness or drowsiness, restlessness, fits,
muscle pain, fatigue or cramps, low blood pressure, difficulty
passing water, fast heart rate and feeling and being sick.
Metabolism: dehydration, gout, changes in levels of body
chemicals (increased blood potassium, glucose or uric acid or
decreased blood sodium), glucose in the urine.
Nervous system: difficulty sleeping or sleepiness, confusion,
nervousness and restlessness, anxiety, dizziness, pins and
needles or tingling, near unconsciousness including reduced
mental activity and response to stimulation (stupor), feeling
of dizziness or spinning (vertigo), tremors and brain disease
(characterised by poor concentration, confusion and
delirium).
Heart: chest pain (angina), pounding (palpitation) heart
beats, dizziness on standing due to low blood pressure and.
Breathing: cough, difficulty breathing, fluid in the lungs and
lung inflammation (pneumonitis).

4:41 PM

Page 2

Stomach and intestines: feeling of stomach fullness,
cramps, stomach irritation or pain, activation of stomach
ulcers, bleeding in the stomach or intestines, indigestion,
wind, loss or other appetite changes, constipation or
diarrhoea, hiccups, feeling or being sick.
Liver: changes in liver function.
Skin: blood spots, discolouring to the skin (purpura) loss of
hair, itching, pale or red irregular raised patches with severe
itching, flushing, sensitivity of the skin to sunlight or
artificial light (e.g. sunbeds), sweating and swelling of the
salivary glands.
Muscles and joints: joint pain, back pain, aching legs.
Urinary and genital: pain on passing water, getting up in
the night to pass water, frequent or copious water production,
bladder pain, impaired kidney function,, decreased desire for
sex and inability to maintain an erection.
Senses: bad taste, stuffy nose, ringing in the ears, increased
pressure in the eyes, visual disturbances and yellow vision.
Other: dry mouth, thirst, back, chest, neck and shoulder pain,
pain in the hands and feet, tiredness, a feeling of general
discomfort and illness, weakness, fever, headache and
fainting.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Co-amilozide

Keep all medicines out of the sight and reach of children
• Do not take this medicine after the expiry date printed
after “EXP” on the carton and blister pack or bottle.
• Store in the original container.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other information

What Co-amilozide tablets contain
The active substance is amiloride hydrochloride and
hydrochlorothiazide. Each tablet contains 5.68mg amiloride
hydrochloride (equivalent to 5mg anhydrous amiloride
hydrochloride) and 50mg of hydrochlorothiazide
The other ingredients are lactose monohydrate, calcium
hydrogen phosphate dehydrate, maize starch, talc, sodium
starch glycolate, magnesium stearate and colour sunset
yellow (E110)
See end of section 2 for further information on lactose and
sunset yellow (E110).
What Co-amilozide tablets look like and contents of the
pack:
Co-Amilozide 5/50mg tablets are pale peach, flat beveled
edge circular tablets embossed with A 5/50 with break line
on one face and PV on the reverse.

Pack sizes for Co-amilozide are 28, 100, 250, 500 & 1000
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio
format or additional copies, please contact the licence
holder at the address (or telephone, fax) above.
PL 04556 / 0041

Reference: 00411015/03

POM

This leaflet was last revised on October 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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